Device ReplacementREPLACENCT00395447
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
An observational study of Device Replacement and Elective Replacement (ERI), run by Biotronik, Inc. at 71 sites in United States.
Trial summary
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device Replacement, Elective Replacement (ERI), Device Advisory
- What is being tested?
- Straight-forward Device Replacement and Device Replacement with Upgrade
- Type of treatment
- Surgery or procedure
- How many people
- 1,744 participants
- Where
- 71 sitesUnited States
- Study dates
- Jul 2007to Jun 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with device replacement procedures at study sites
Who may be able to join
- Is able to give informed consent
- Is identified for generator replacement without system modification or generator replacement including planned system modification, regardless of generator manufacturer
- Is clinically stable to tolerate the surgical procedure
- Age 18 years or greater
- Is geographically stable and able to return to the investigational site for follow-up care through the six-month visit
Who cannot join
- Inability or unwillingness to give informed consent
- Current system infection requiring generator explantation or lead extraction
- Generator replacement requiring planned lead extraction
- Participating in another cardiovascular investigational drug or device registry
- A life expectancy of less than six months
- Expected to receive a heart transplant within 6 months
- All vulnerable subjects as defined by the FDA Office of Human Research Protection or the local IRB providing oversight
Trial locations and contacts
71 sites in 1 country.
71 sites in 1 country
United States71 sites
Abington Medical Specialists
Abington, Pennsylvania, 19454
Amarillo Heart
Amarillo, Texas, 79106
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University Clinic
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Midatlantic Cardiovascular Associates
Baltimore, Maryland, 21218
Union Memorial Hospital
Baltimore, Maryland, 21218
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts University
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
New England Cardiovascular Specialists
Boston, Massachusetts, 02135
Manatee Memorial
Bradenton, Florida, 34209
Buffalo Heart Group
Buffalo, New York, 14214
Lahey Clinic
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29403
CAMC Memorial Hospital
Charleston, West Virginia, 25304
The University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals Cleveland
Cleveland, Ohio, 44106
Heart and Vascular Center, MetroHealth MC
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Penrose Hospital
Colorado Springs, Colorado, 80907
South Carolina Heart Center
Columbia, South Carolina, 29204
Christus Spohn
Corpus Christi, Texas, 78404
UT Southwestern
Dallas, Texas, 75390
Halifax Medical Center
Daytona Beach, Florida, 32114
Aurora Denver Cardiology
Denver, Colorado, 80012
Duke University Medical Center
Durham, North Carolina, 27715
Sacred Heart Medical Center
Eugene, Oregon, 97401
Pee Dee Cardiology
Florence, South Carolina, 29506
Heart Center of North Texas
Fort Worth, Texas, 76104
Forrest General Hospital
Hattiesburg, Mississippi, 39402
Baptist Jacksonville
Jacksonville Beach, Florida, 32250
University of Kansas Hospital
Kansas City, Kansas, 66160
Mid America Heart
Kansas City, Missouri, 64111
Louisiana Heart
Lafayette, Louisiana, 70503
Central Baptist
Lexington, Kentucky, 40503
Loyola University
Maywood, Illinois, 60153
Mesa Cardiovascular
Mesa, Arizona, 85206
Mt. Sinai Medical Center
Miami Beach, Florida, 33140
Stanislaus Cardiology
Modesto, California, 95355
Vanderbilt University
Nashville, Tennessee, 37232
Tulane University
New Orleans, Louisiana, 70112
St. Luke's Roosevelt Hospital
New York, New York, 10025
Sentara Norfolk General Hospital
Norfolk, Virginia, 23502
OU Medical Center Presbyterian
Oklahoma City, Oklahoma, 73104
Heart Consultants Omaha
Omaha, Nebraska, 68122
Alegent Hospitals
Omaha, Nebraska, 68124
Creighton University
Omaha, Nebraska, 68131
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Oregon Health Sciences University
Portland, Oregon, 97239
Desert Cardiology
Rancho Mirage, California, 92270
Wuesthoff Hospital
Rockledge, Florida, 32955
Shady Grove Adventist
Rockville, Maryland, 20850
Mercy General Hospital
Sacramento, California, 95819
North Shore Medical Center
Salem, Massachusetts, 01970
UCSD Medical Center
San Diego, California, 92103
UCSF
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29307
Barnes Jewish Hospital
St Louis, Missouri, 63110
Bayfront Medical Center
St. Petersburg, Florida, 33705
University of South Florida
Tampa, Florida, 33606
Hillcrest Medical Center
Tulsa, Oklahoma, 74104
George Washington University
Washington D.C., District of Columbia, 20037
St. Barnabas
West Orange, New Jersey, 07052
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197
Florida Medical Center
Zephyrhills, Florida, 33542
About this study
Official title: Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.
Read the detailed description
Device replacements occur for many reasons, including elective replacement indication (ERI), manufacturer advisory, and upgrade.
Recently pacemaker and implantable cardioverter (ICD) advisories have created a dilemma for both physicians and patients. While the risk of device malfunction is low, replacement rates following an advisory are usually high and complication rates following device replacement are not widely known. One retrospective analysis of ICD advisories in Canada reported an 18.3% replacement rate, and subsequent 8.1% complication rate directly related to the replacement.
Device replacements also occur in order to upgrade an existing system. Clinical studies have shown that cardiac resynchronization therapy (CRT) significantly reduces all-cause mortality and hospitalization in patients with advanced heart failure (HF). As a result of expanding indications for this therapy, many standard ICD patients are being upgraded to CRT-D systems. Complication rates related to upgrades of these systems are also not widely known.
To our knowledge, the risk of complications following a device replacement has not been studied prospectively in any patient population. Limited data are available to guide physicians when weighing the risks and benefits of device replacement.
This is a prospective multi-center study. 1750 patients at 100 clinical sites will be enrolled prior to generator replacement. Patients will be implanted and followed for 6 months to assess any complications related to the replacement procedure.
Patients with any legally marketed device for explant can be enrolled. The replacement device can be from any manufacturer.
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade, Postoperative Complications
- Being tested
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Keywords
- Cardiac Pacemaker, Defibrillator, Replacement, Upgrade
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight-forward Device ReplacementProcedure or surgery
Device Replacement with UpgradeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Straight-forward Device Replacement | Subject with a straight-forward device replacement without lead revisions or additions. Receives: Procedure: Straight-forward Device Replacement | |
| Device Replacement with Upgrade | Subjects with a device replacement and planned lead upgrade, revision, or addition. Receives: Procedure: Device Replacement with Upgrade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)
The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Device ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeanne Poole, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395447
- Sponsor's protocol ID
- REPLACE
- Acronym
- REPLACE
- Status last verified
- Mar 2015
- First submitted
- 1 Nov 2006
- Last updated
- 14 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chung MK, Holcomb RG, Mittal S, Steinberg JS, Gleva MJ, Mela T, Uslan DZ, Mitchell K, Poole JE; REPLACE Investigators. REPLACE DARE (Death After Replacement Evaluation) score: determinants of all-cause mortality after implantable device replacement or upgrade from the REPLACE registry. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1048-56. doi: 10.1161/CIRCEP.114.001671. Epub 2014 Sep 14.
PubMed 25221331Uslan DZ, Gleva MJ, Warren DK, Mela T, Chung MK, Gottipaty V, Borge R, Dan D, Shinn T, Mitchell K, Holcomb RG, Poole JE. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol. 2012 Jan;35(1):81-7. doi: 10.1111/j.1540-8159.2011.03257.x. Epub 2011 Nov 11.
PubMed 22077194Poole JE, Gleva MJ, Mela T, Chung MK, Uslan DZ, Borge R, Gottipaty V, Shinn T, Dan D, Feldman LA, Seide H, Winston SA, Gallagher JJ, Langberg JJ, Mitchell K, Holcomb R; REPLACE Registry Investigators. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010 Oct 19;122(16):1553-61. doi: 10.1161/CIRCULATIONAHA.110.976076. Epub 2010 Oct 4.
PubMed 20921437
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade
- ClinicalTrials.gov ID
- NCT00395447
- Acronym / sponsor ID
- REPLACE / REPLACE
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade, Postoperative Complications
- Keywords
- Cardiac Pacemaker, Defibrillator, Replacement, Upgrade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,744 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Nov 2006 (estimated)
- Results
- Posted 30 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.
Detailed description
Device replacements occur for many reasons, including elective replacement indication (ERI), manufacturer advisory, and upgrade.
Recently pacemaker and implantable cardioverter (ICD) advisories have created a dilemma for both physicians and patients. While the risk of device malfunction is low, replacement rates following an advisory are usually high and complication rates following device replacement are not widely known. One retrospective analysis of ICD advisories in Canada reported an 18.3% replacement rate, and subsequent 8.1% complication rate directly related to the replacement.
Device replacements also occur in order to upgrade an existing system. Clinical studies have shown that cardiac resynchronization therapy (CRT) significantly reduces all-cause mortality and hospitalization in patients with advanced heart failure (HF). As a result of expanding indications for this therapy, many standard ICD patients are being upgraded to CRT-D systems. Complication rates related to upgrades of these systems are also not widely known.
To our knowledge, the risk of complications following a device replacement has not been studied prospectively in any patient population. Limited data are available to guide physicians when weighing the risks and benefits of device replacement.
This is a prospective multi-center study. 1750 patients at 100 clinical sites will be enrolled prior to generator replacement. Patients will be implanted and followed for 6 months to assess any complications related to the replacement procedure.
Patients with any legally marketed device for explant can be enrolled. The replacement device can be from any manufacturer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straight-forward Device Replacement | – | Procedure: Straight-forward Device ReplacementSubject with a straight-forward device replacement without lead revisions or additions. |
| Device Replacement with Upgrade | – | Procedure: Device Replacement with UpgradeSubjects with a device replacement and planned lead upgrade, revision, or addition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with device replacement procedures at study sites
Key inclusion criteria (5 listed)
- Is able to give informed consent
- Is identified for generator replacement without system modification or generator replacement including planned system modification, regardless of generator manufacturer
- Is clinically stable to tolerate the surgical procedure
- Age 18 years or greater
- Is geographically stable and able to return to the investigational site for follow-up care through the six-month visit
Key exclusion criteria (7 listed)
- Inability or unwillingness to give informed consent
- Current system infection requiring generator explantation or lead extraction
- Generator replacement requiring planned lead extraction
- Participating in another cardiovascular investigational drug or device registry
- A life expectancy of less than six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straight-forward Device Replacement | Procedure or surgery | Straight-forward Device Replacement |
| Device Replacement with Upgrade | Procedure or surgery | Device Replacement with Upgrade |
Primary outcome
Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)
Time frame: 6 months
The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25221331Chung MK, Holcomb RG, Mittal S, Steinberg JS, Gleva MJ, Mela T, Uslan DZ, Mitchell K, Poole JE; REPLACE Investigators. REPLACE DARE (Death After Replacement Evaluation) score: determinants of all-cause mortality after implantable device replacement or upgrade from the REPLACE registry. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1048-56. doi: 10.1161/CIRCEP.114.001671. Epub 2014 Sep 14.
- Derived from this study: PubMed 22077194Uslan DZ, Gleva MJ, Warren DK, Mela T, Chung MK, Gottipaty V, Borge R, Dan D, Shinn T, Mitchell K, Holcomb RG, Poole JE. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol. 2012 Jan;35(1):81-7. doi: 10.1111/j.1540-8159.2011.03257.x. Epub 2011 Nov 11.
- Derived from this study: PubMed 20921437Poole JE, Gleva MJ, Mela T, Chung MK, Uslan DZ, Borge R, Gottipaty V, Shinn T, Dan D, Feldman LA, Seide H, Winston SA, Gallagher JJ, Langberg JJ, Mitchell K, Holcomb R; REPLACE Registry Investigators. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010 Oct 19;122(16):1553-61. doi: 10.1161/CIRCULATIONAHA.110.976076. Epub 2010 Oct 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Poole, MD principal investigator
University of Washington
71 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Device Replacement and Elective Replacement (ERI), run by Biotronik, Inc. at 71 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395447, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.